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'Pilot trial of Pegilated Liposomal Doxorrubicin (Caelyx) in combination with Docetaxel (Taxotere) in advanced breast cancer patients' Estudio Piloto de Doxorrubicina Liposomal Pegilada (Caelyx) en combinación con Docetaxel (Taxotere) en pacientes con cáncer de mama avanzado

'Pilot trial of Pegilated Liposomal Doxorrubicin (Caelyx) in combination with Docetaxel (Taxotere) in advanced breast cancer patients' Estudio Piloto de Doxorrubicina Liposomal Pegilada (Caelyx) en combinación con Docetaxel (Taxotere) en pacientes con cáncer de mama avanzado

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001499-10-ES
Enrollment
Unknown
Registered
2006-04-28
Start date
2005-05-19
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer

Interventions

Trade Name: Caelyx Product Name: Caelyx Product Code: EU/1/96/011/001 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DOXORRUBICINA CLORHIDRATO LIPOSOMAL PEGILADA Conce

Sponsors

Dr. José Ramón Mel Lorenzo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Aged > 18 years Histologic diagnostic of breast cancer Performance status of Karnofsky > 60% Left ventricular ejecction > 50% Hepatic and medular funtions adecuated Mensurable lesions of metastatic breast cancer No previous chemotherapy treatments for metastasic disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: No cardiopathy history No hipersensibility for antraciclines therapy No treatment failure to antraciclines therapy in previous 12 months

Design outcomes

Primary

MeasureTime frame
Main Objective: To value efficiency of Caelyx (30mg/m2) in combination with Docetaxel (60mg/m2) in a pilot trial administrated in 3 weeks-cicles during 6 cicles in advanced breast cancer patients;Secondary Objective: To value segurity and tolerance of the combination Pegilated Liposomal Doxorubicin (Caelyx) and Docetaxel (Taxotere) as teraphy in advanced breast cancer ;Primary end point(s): Overall response rate—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026